CompletedNCT03276884Updated Dec 3, 2018

Growth and Tolerance of Young Infants

An interventional study of Experimental Infant Formula and Control Infant Formula in Growth, sponsored by Abbott Nutrition. Completed at 22 sites in United States. Open to participants aged Up to 8 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-03.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 267
Allocation: Randomized
Ages: Up to 8 Days
Sex: All

Study summary

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Conditions studied

Growth

Who can participate

Ages eligible: Up to 8 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subject is judged to be in good health.
Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
Birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
Subject is between 0 and 8 days of age at enrollment.
Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion criteria

Exclusion Criteria:

An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
Subject participates in another study that has not been approved as a concomitant study.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 267 participants (actual)

Study arms

Experimental
Experimental Infant Formula
Infant formula powder to be fed ad libitum
Other: Experimental Infant Formula
Active comparator
Control Infant Formula
Infant formula powder to be fed ad libitum
Other: Control Infant Formula

Interventions

OtherExperimental Infant Formula
amino acid-based infant formula powder
OtherControl Infant Formula
amino acid-based infant formula powder

What researchers measure

Primary outcomes

Weight Gain
Infant scale
Time frame: Study Day 14 to Study Day 119

Secondary outcomes

GI tolerance
Parent completed questionnaires
Time frame: Study Day 1 to Study Day 119
Length
Length board
Time frame: Study Day 1 to Study Day 119
Head Circumference
Measure tape
Time frame: Study Day 1 to Study Day 119
Weight
Infant scale
Time frame: Study Day 1 to Study Day 119

Study locations

22 sites

Alabama Clinical Therapeutics, LLC
Birmingham, Alabama 35235, United States
Southeastern Pediatric Associates
Dothan, Alabama 36305, United States
Watching Over Mothers and Babies
Tucson, Arizona 85712, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas 72401, United States
Norwich Pediatric Group, PC
Norwich, Connecticut 06360, United States
Children's Research, LLC
Lake Mary, Florida 32746, United States
Score Physician Alliance, LLC
Saint Petersburg, Florida 33710, United States
Saltzer Medical Group
Nampa, Idaho 83686, United States
Deaconess Clinic, Inc.
Evansville, Indiana 47713, United States
Springs Medical Research
Owensboro, Kentucky 42303, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska 68510, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio 45014, United States
Institute of Clinical Research, LLC
Mentor, Ohio 44060, United States
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio 44130, United States
Medical Research South
Charleston, South Carolina 29407, United States
Coastal Pediatric Research 3002
Charleston, South Carolina 29414, United States
Coastal Pediatric Associates 3004
Mount Pleasant, South Carolina 29464, United States
Coastal Pediatric Research 3003
North Charleston, South Carolina 29406, United States
Memphis & Shelby County Pediatric Group
Memphis, Tennessee 38116, United States
Vilo Research Group Inc
Houston, Texas 77017, United States
Southwest Children's Research Associates, PA
San Antonio, Texas 78229, United States
Tanner Clinic
Layton, Utah 84041, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03276884
Lead sponsor: Abbott Nutrition
Responsible party: Sponsor
First posted: Sep 8, 2017
Start date: Oct 11, 2017
Primary completion: Nov 8, 2018
Completion: Nov 8, 2018
Last update: Dec 3, 2018

Study contacts

Jan Kajzer, MS, RD, LD

study chair · Abbott Nutrition

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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